PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
Device Facts
| Record ID | K901762 |
|---|---|
| Device Name | PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM |
| Applicant | Automatic Liquid Packaging, Inc. |
| Product Code | BTT · Anesthesiology |
| Decision Date | Jul 17, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5450 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.